Comparative Study of Metformin Versus Doxycycline in Mode... | NCT06252194

Studies
Comparative Study of Metformin Versus Doxycycline in Moderate to Severe Adult Acne Vulgaris Patients.

NCT06252194

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status

Unknown status

Last Update Posted

Feb 9, 2024Actual

Enrollment

120Estimated

Phase

Phase 2

Conditions

Acne Vulgaris

Interventions

Metformin and doxycycline

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2023Actual

Primary Completion Date

Mar 2024Estimated

Completion Date

Mar 2024Estimated

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Feb 7, 2024

First Posted Date

Feb 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2024

Last Update Posted Date

Feb 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Muhammad Marnush, Principal Investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPrincipal Investigator

Lead Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not.

Patients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group.

Researcher will compare the clinical improvement in two groups.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Metformin 500 mg twice daily along with topical retinoids for 12 weeks	Drug: Metformin and doxycycline
Group B	Active Comparator	Doxycycline 100 mg twice daily along with topical retinoids for 12 weeks	Drug: Metformin and doxycycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin and doxycycline	Drug	Metformin 500 mg tablet twice daily	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global Acne Grading System (GAGS) Score	Acne Vulgaris Severity assesment by GAGS score	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed moderate and severe AV patients diagnosed by a dermatologist

Exclusion Criteria:

Patients receiving topical retinoids within last two months
Pregnancy and lactation
History of corticosteroids intake
Suffering from malignancy or any cosmetic induced acne

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Muhammad Marnush, MBBS	Contact	88001714558447		marnushm@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BSMMU	Recruiting	Dhaka			Bangladesh

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin
D004318	Doxycycline

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D013754

Browse Leaves

Not provided

Browse Branches

Not provided